SPL v1
SPL
SPL Set ID adee17d1-6fc3-574d-e053-2a95a90a78a1
Route
TOPICAL
Published
Effective Date 2020-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-28
Description

Ethyl Alcohol 75% v/v

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75% v/v

Uses

Hand sanitizer to help reduce bacteria on the skin

Warnings
  • Flammable. Keep away from fire or flame.
  • For external use only
Directions

Wipe hands; discard after use

Active Ingredient

Ethyl Alcohol 75% v/v

Other Information

May discolor certain fabrics or surfaces

Inactive Ingredients

Purified Water

When Using This Product

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Discontinue Use and Ask A Doctor If

Discontinue use and ask a doctor if irritation or rash appears and lasts

Package Label/principal Display Panel

NDC 79367-001-01; 225 mL

Structured Label Content

Uses

Hand sanitizer to help reduce bacteria on the skin

Purpose

Antimicrobial

Warnings
  • Flammable. Keep away from fire or flame.
  • For external use only
Directions

Wipe hands; discard after use

Active Ingredient

Ethyl Alcohol 75% v/v

Other Information

May discolor certain fabrics or surfaces

Inactive Ingredients

Purified Water

When Using This Product (When using this product)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Discontinue Use and Ask A Doctor If (Discontinue use and ask a doctor if)

Discontinue use and ask a doctor if irritation or rash appears and lasts

Package Label/principal Display Panel (Package Label/Principal Display Panel)

NDC 79367-001-01; 225 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:36.069698 · Updated: 2026-03-14T22:58:12.530478